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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020232
Company: ACTAVIS LABS UT INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FIORICET W/ CODEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription AB Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/30/1992 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2024 SUPPL-48 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020232Orig1s048ltr.pdf
12/15/2023 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020232s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020232Orig1s047ltr.pdf
03/04/2021 SUPPL-45 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020232s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020232Orig1s045ltr.pdf
10/07/2019 SUPPL-44 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020232s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020232Orig1s044ltr.pdf
09/18/2018 SUPPL-43 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020232Orig1s042s043ltr.pdf
09/18/2018 SUPPL-42 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020232Orig1s042s043ltr.pdf
08/29/2017 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020232Orig1s041ltr.pdf
12/16/2016 SUPPL-40 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020232Orig1s040ltr.pdf
07/31/2015 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.
06/16/2015 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.
06/05/2014 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
10/18/2013 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s036ltr.pdf
05/09/2013 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020232Orig1s035ltr.pdf
06/22/2011 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020232s033ltr.pdf
03/21/2008 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020232s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020232s021ltr.pdf
04/26/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
01/03/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
05/22/2001 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
05/30/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.
10/04/2001 SUPPL-12 Labeling

Label is not available on this site.
08/03/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
04/22/1999 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/20/1998 SUPPL-8 Labeling

Label is not available on this site.
11/08/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
01/18/1996 SUPPL-4 Labeling

Label is not available on this site.
03/29/1994 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/01/1992 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/15/2023 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020232s047lbl.pdf
03/04/2021 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020232s045lbl.pdf
10/07/2019 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020232s044lbl.pdf
09/18/2018 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf
09/18/2018 SUPPL-42 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020232s042s043lbl.pdf
08/29/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020232s041lbl.pdf
12/16/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf
12/16/2016 SUPPL-40 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf
12/16/2016 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020232s040lbl.pdf
10/18/2013 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s036lbl.pdf
05/09/2013 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020232s035lbl.pdf
06/22/2011 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020232s033lbl.pdf
03/21/2008 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020232s021lbl.pdf

FIORICET W/ CODEINE

CAPSULE;ORAL; 325MG;50MG;40MG;30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 215138 HIKMA
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 076560 LGM PHARMA
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription No AB 204649 STRIDES PHARMA
FIORICET W/ CODEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Prescription Yes AB 020232 ACTAVIS LABS UT INC
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